MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPR SRS IC SEG - 60MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 07/23/2014

Event Type  Injury  

Event Description

It was reported patient underwent a left comprehensive segmental revision system procedure on an unknown date.Subsequently, a revision procedure has been indicated due to dislocation; however, no revision procedure has been reported to date.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided: expiration date - unknown.Date implanted - unknown.Initial reporter - unknown.Pma/510(k) number.Manufacture date ¿ unknown.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: ¿dislocation, subluxation, loosening, migration, screw back-out and/or fracture of the implants can occur¿.

Event Description

It was reported that the patient underwent a comprehensive reverse shoulder arthroplasty on (b)(6) 2013.Subsequently, the patient was revised on (b)(6) 2014 due to dislocation.During the procedure, the surgeon noted that the implant was too long and would not reduce.The intercalary segment was removed and a shorter segment was implanted.

• Brand Name: COMPR SRS IC SEG - 60MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 3951084
• MDR Text Key: 4645658
• Report Number: 0001825034-2014-06330
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/01/2013
• Device Model Number: N/A
• Device Catalogue Number: 211225
• Device Lot Number: 947300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention